Biogen/Samsung Bioepis End Patent Dispute with AbbVie

Biogen and partner Samsung Bioepis have reached agreement with AbbVie regarding the commercialization of Imraldi, their biosimilar form of the latter’s blockbuster Humira.

Specific terms of the deal were not disclosed, but AbbVie has granted patent licenses for the use and sale of Imraldi in Europe on a country-by-country basis, while Biogen and Samsung Bioepis will make royalty payments in return. The companies have agreed to dismiss all pending patent litigation.

Biogen said it expects to launch Imraldi in Europe in October. “Biogen already markets two biosimilars in Europe and the planned introduction of Imraldi on October 16 could potentially expand patient choice by offering physicians more options to meet the needs of patients while delivering significant savings to healthcare systems,” said Ian Henshaw, global head of biosimilars at Biogen.

Imraldi was approved by the European Commission in August 2017 but it is not yet authorized in the US. Under terms of the agreement, it may be launched in the US, if approved, from Jun. 30, 2023 onward.

Humira is a monoclonal antibody with sales of about $15 billion across its range of indications for chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and ankylosing spondylitis.